Engineer II, Computer Systems Validation

Description

The role is an Engineer II in Computer Systems Validation at a site in Greenville, North Carolina that makes sterile and oral solid dose products for pharmaceutical and biotech clients.

The company is a global provider of integrated drug development and manufacturing services, and the site runs on advanced technology and close teamwork.

Work is mainly change management and validation of existing commercial manufacturing systems, covering automation, equipment and computerized systems across the site.

The work sits in a GMP environment, so some PPE is required, such as safety glasses, gowning, gloves, lab coat or ear plugs, and safety standards must be followed.

This role is mainly about CSV, with possible exposure to capital projects over time, but you will not lead full-scale capital validation projects at this level.

You will grow with guidance from experienced team members.

Responsibilities

• Assess changes to existing manufacturing systems, equipment and related databases.
• Support change management for commercial production lines.
• Write and run validation documents, including IQ/OQ/PQ protocols and qualification plans.
• Carry out risk assessments, validation assessments and gap analyses to decide what testing is needed.
• Work with automation and engineering teams to qualify system changes.
• Help validate automation and control systems such as PLC, SCADA, DCS and DeltaV.
• Make sure work meets cGMP, FDA and industry standards.
• Keep validation documentation accurate and compliant.
• Take part in continuous improvement and operational excellence work.

Requirements

• Bachelor's degree in engineering, life sciences, chemistry or a related technical field is required. Equivalent mixes of education, training and relevant experience may be considered instead.
• About 2 years of experience in validation, CSV or a GMP-regulated environment is preferred but not required. Internships, co-ops or academic projects in validation, automation or regulated industries also count.
• Working knowledge of cGMP and regulated environments.
• Some exposure to CSV, CQV or automation validation.
• Familiarity with automation and control systems such as PLCs, SCADA, DCS, DeltaV and Allen-Bradley.
• Ability to help develop IQ/OQ/PQ protocols.
• Strong technical writing and documentation skills.
• Basic understanding of risk assessments and gap analysis.
• Strong analytical and problem-solving skills.
• Clear communication and good teamwork.
• Ability to juggle several tasks in a busy setting.
• Proficiency with Microsoft Office.
• Preferred, not required: experience working with automation engineers or manufacturing systems.
• Preferred, not required: exposure to change management in regulated environments.
• Preferred, not required: familiarity with quality systems and the validation lifecycle.

Conditions

Standard schedule, Monday to Friday, 8:00 AM to 5:00 PM.

Off-hours flexibility is needed during shutdowns or system availability windows.

Fully onsite in Greenville, NC.

Work may take place in manufacturing or controlled areas as needed.

Equal opportunity employer.